Configuring VMSR Reporting (Product Surveillance)

Your organization may opt to participate in the FDA’s Voluntary Malfunction Summary Reporting (VMSR) program, which permits manufacturers to report certain device malfunction Medical Device Reports (MDRs) in an aggregated, summary format on a quarterly basis. This program is used by medical device manufacturers with a high volume of complaints to reduce the workload of filing individual eMDRs for every reportable complaint. Manufacturers need to submit separate summary reports for each unique combination of brand name, device model, and problem code(s). Each summary report identifies the total number of reportable malfunctions.

By leveraging configurable Summary Report Profiles, Product Surveillance can automatically assess Complaints and Reportability Assessments to determine if an incident qualifies for Summary Reporting, significantly reducing manual effort and assessment time for Vigilance Specialists and ensuring regulatory compliance.

Managing Summary Report Profiles

Summary Report Profiles define groups for summary reporting based on the Product or Product Variant and the severity.

Before creating Summary Report Profile records, you must perform the following configuration steps:

  • Display the following objects in Business Admin:
    • Summary Report Profile
    • Summary Report Products Scope
    • Summary Report - Codes
  • Add the following Related Object sections to the Summary Report Profile object layout:
    • Summary Report Products Scope
    • Summary Report - Code > Code
  • Optional: Activate the Override Justification field on the Reportability Assessment Effects object.

Creating Summary Report Profiles

To create a Summary Report Profile:

  1. Navigate to Business Admin > Objects > Summary Report Profile and click Create.
  2. Enter a Name.
  3. Select the Allowed Severities.
  4. Select a Code Eligibility.
  5. Optional: Select a Country.
  6. Optional: Select an Expiration Date.
  7. Select a Start Date.
  8. Optional: Enter an HA Authorization Number.
  9. Select a Reporting Requirement.
  10. Click Save or click Save + Create to add another Summary Report Profile.

Creating Summary Report Product Scopes & Codes

To create a Summary Report Product Scope:

  1. Navigate to Business Admin > Objects > Summary Report Products Scope and click Create.
  2. Enter a Name.
  3. Select the appropriate Summary Report Profile.
  4. Select one of following:
    1. Product Family
    2. Product
    3. Product Variant
    4. Material
  5. Click Save or click Save + Create to create another Summary Report Products Scope record.

Creating Summary Report - Codes

To create a Summary Report - Code:

  1. Navigate to Business Admin > Objects > Summary Report - Codes and click Create.
  2. Select a Summary Report Profile.
  3. Select a Code.
  4. Click Save or click Save + Create to create another Summary Report - Code record.

You can complete all the steps in this article with the standard System Administrator or Vault Owner security profile. If your Vault uses custom security profiles, your profile must grant the following permissions:

Type Permission Controls
Security Profile Object: Summary Report Profile: Read, Create, Edit, Delete Ability to manage Summary Report Profile records.
Security Profile Object: Summary Report Product Scope: Read, Create, Edit, Delete Ability to manage Summary Report Product Scope records.
Security Profile Object: Summary Report - Codes: Read, Create, Edit, Delete Ability to manage Summary Report - Code records.